New Arterial Sheath for Stroke and Other Neurovascular Interventions.

用于中风和其他神经血管干预的新动脉鞘。

• 批准号: 10253315
• 负责人: Mubin Syed
• 金额: $ 109.57万
• 依托单位: RAM MEDICAL INNOVATIONS, INC.
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-08-15 至 2023-08-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10253315
• 关键词: Acute; Adhesions; Aging; Anatomy; Animal Model; Autopsy; Blood; Blood Circulation; Blood Platelets; Blood Vessels; Brain; Cadaver; Carotid Arteries; Catheters; Cause of Death; Cerebrum; Cessation of life; Classification; Clinical; Coagulation Process; Complication; Cyclic GMP; Data; Data Analyses; Development; Devices; Dose; Elderly; Endothelial Cells; Endothelium; Ensure; Evaluation; Excision; FDA approved; Failure; Family suidae; Feasibility Studies; Fluoroscopy; Grant; Guidelines; Health care facility; Hour; Human; Humidity; In Vitro; Incidence; Injury; Intervention; Investments; Ischemic Stroke; Legal patent; Life; Manufacturer Name; Measurement; Measures; Medical; Medical Device; Modeling; Outcome; Particulate; Patients; Performance; Phase; Positioning Attribute; Preparation; Probability; Procedures; Process; Protocols documentation; Radiation exposure; Reperfusion Therapy; Resistance; Risk; Safety; Savings; Sheep; Shipping; Silicones; Site; Speed; Stents; Sterilization; Stroke; Symptoms; Technology; Temperature; Test Result; Testing; Therapeutic Embolization; Thrombectomy; Time; Tube; United States; Vascular Endothelium; Work; aortic arch; base; biomaterial compatibility; cytotoxicity; design; disability; functional independence; head-to-head comparison; hemocompatibility; human old age (65+); hydrophilicity; improved; in vivo; innovation; intracranial artery; irritation; neurovascular; next generation; novel; particle; phase 2 study; prevent; prototype; radiologist; seal; standard of care; stroke intervention; stroke therapy; success; systemic toxicity; tool

Project Summary/Abstract Stroke, including ischemic stroke, is the 2nd leading cause of death in the world and 5th leading cause of death in the United States. Recent breakthrough advances in device technology have resulted in endovascular stroke treatment becoming the standard of care. However, stroke thrombectomy (intervention) is time sensitive with a window to intervene in less than 16 hours following symptom onset. Patients rarely arrive to the care facility immediately following the onset of symptoms. It is well-known that complications directly increase in proportion to procedure time, specifically 1) a 7.7% decreased probability of functional independence for every hour of stroke onset to successful reperfusion (“time is brain” concept), and 2) sometimes death. In addition, these time sensitive procedures are limited due to tortuous anatomy, prevalent in the elderly (in up to 35%). This in turn also results in higher complication rates and lessens the chance of procedural success. Specifically, neurointerventionalists struggle with difficult anatomy and often are unable to perform these potentially life-saving procedures in 28.9% of patients. Not only is there a delay in reaching the target intracranial artery, but radiation exposure and contrast dose can also rise, placing the patient at additional risk. Therefore, there is a tremendous need for a device to decrease the failure rate and improve the speed of this procedure in difficult tortuous aortic anatomy. RAM Medical Innovations (RAM) has developed a novel carotid sheath that can quickly and safely navigate as well as maintain stable position in this hostile anatomy. RAM's feasibility work showed significantly faster carotid sheath insertion success rate, less endothelial injury, and reduced radiation exposure with our nonlubricious prototype against predicate devices, all of which have an advantageous hydrophilic coating. In this Direct to Phase 2 grant RAM plans to make and test the finalized, lubricious sheath device to demonstrate the product's safety and time efficiency profile. Notably, RAM's device, using a lubricious component found in other FDA approved devices seeks to reduce the potential risk of particle shedding seen with current predicates. In preparation for FDA 510(k) application, Class II device, RAM proposes biocompatibility testing in compliance with the FDA guidelines and ISO protocols. This would include cytotoxicity, sensitization, irritation, systemic toxicity (acute) and hemocompatibility, using in vitro and animal models to establish measurements within acceptable ranges. RAM also plans to perform device sterilization, design verification, packaging and accelerated aging tests that will ensure that the product will perform reliably one-year and two-years post sterilization. Packaging and sterilization testing will also be completed to conform to FDA and ISO standards. Additionally, after each testing process, the device will be functionally tested to ensure that the design is still robust. Successful outcomes in testing and development will result in a new promising tool to deliver stroke treatment efficiently and safely even in patients with difficult aortic anatomy. RAM has obtained third party investments and, after obtaining FDA clearance, intends to partner with or sell the product to a major medical device manufacturer for commercial deployment.

项目总结/摘要 中风，包括缺血性中风，是世界上第二大死亡原因和第五大死亡原因 在美国最近器械技术的突破性进展导致了血管内中风 治疗成为护理标准。然而，卒中血栓切除术（干预）具有时间敏感性， 在症状发作后不到16小时内进行干预。患者很少到达护理机构 在症状出现后立即进行。众所周知，并发症直接增加的比例 具体而言，1）每小时功能独立性降低7.7%， 中风发作到成功再灌注（“时间就是大脑”概念），和2）有时死亡。此外，这些时间 由于在老年人中普遍存在的迂曲解剖结构（高达35%），敏感手术受到限制。这反过来 还导致更高的并发症发生率并减少手术成功的机会。具体地说， 神经介入医生与困难的解剖结构作斗争，通常无法执行这些可能挽救生命的手术。 28.9%的患者进行了手术。不仅到达目标颅内动脉有延迟， 曝光和造影剂剂量也会增加，使患者处于额外的风险中。因此， 需要一种器械来降低失败率并提高该手术在复杂迂曲主动脉中的速度 解剖学RAM Medical Innovations（RAM）开发了一种新型颈动脉鞘，可以快速安全地 在这个充满敌意的环境中导航并保持稳定的位置。RAM的可行性研究显示， 更快的颈动脉鞘插入成功率，更少的内皮损伤，并减少辐射暴露与我们的 非润滑原型与等同器械相比，所有器械均具有有利的亲水涂层。在这 直接进入第2阶段，授予RAM计划制造和测试最终的润滑鞘管器械，以证明 产品的安全性和时效性。值得注意的是，RAM的设备，使用在其他设备中发现的润滑成分， FDA批准的器械旨在降低当前同品种器械的颗粒脱落潜在风险。在 准备FDA 510（k）申请，II类器械，RAM建议生物相容性试验符合要求 符合食品药品监督管理局和国际标准化组织的规定这将包括细胞毒性、致敏性、刺激性、全身性 毒性（急性）和血液相容性，使用体外和动物模型建立测量值， 可接受的范围。RAM还计划进行器械灭菌、设计验证、包装和 加速老化测试，确保产品在一年和两年后可靠运行 灭菌还将完成包装和灭菌试验，以符合FDA和ISO标准。 此外，在每个测试过程后，将对器械进行功能测试，以确保设计仍然 健壮。测试和开发的成功结果将产生一种新的有前途的工具， 即使在主动脉解剖结构困难的患者中也能有效、安全地治疗。RAM已获得第三方 投资，并在获得FDA许可后，打算与大型医疗机构合作或将产品出售给大型医疗机构。 用于商业部署的设备制造商。